There has been a recent update to the ISTA 3E testing procedure and PCL is here to help you determine how this change will impact your upcoming product launches. This update comes following a technical review completed through ISTA’s approval process and is meant to enhance clarity and testing efficiency.
Key updates include:
- Compression formula alignment
- Optional pallet on top during compression testing
- Impact sequence clarifications
Compression Formula Alignment
This compression formula has reverted to the previous revision of ISTA 3E. The standard now aligns with the simplified formula in ISTA 3H, making it much easier to calculate and understand. ISTA 3E now specifies that the largest stack is used when calculating compression. This should feel like a familiar practice for medical device manufacturers who frequently determine their worst-case configuration for testing.
Optional Pallet on Top During Compression Testing
ISTA 3E no longer requires an additional pallet on top of the sample during compression testing. It is now up to the individual manufacturers to decide if the inclusion of an additional pallet would be beneficial to their test results.
Impact Sequence Clarification
New updates to incline, horizontal, and rotational impact sequences will increase the flexibility of these tests. It is still a requirement that all edges or faces be impacted. This update is simply meant to improve test efficiency, as laboratories can now determine the order in which impacts and drops are performed.
How will this affect your product launch?
These changes aren’t likely to derail most launches. A few re-calculations and documentation updates should keep timelines running smoothly. While these specific updates are low-impact, it’s important to stay informed on the latest standards to ensure you remain compliant with all regulatory requirements.